Gilotrif Side Effects
Generic Name: afatinib
Note: This document contains side effect information about afatinib. Some of the dosage forms listed on this page may not apply to the brand name Gilotrif.
Some side effects of Gilotrif may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to afatinib: oral tablet
Along with its needed effects, afatinib (the active ingredient contained in Gilotrif) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking afatinib:More common
- Bloody or cloudy urine
- burning, dry, or itching eyes
- difficult, burning, or painful urination
- discharge or excessive tearing
- frequent urge to urinate
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- redness, swelling, or pain of the skin
- scaling of the skin on the hands and feet
- tingling of the hands and feet
- ulceration of the skin
- difficult breathing
- shortness of breath
Get emergency help immediately if any of the following symptoms of overdose occur while taking afatinib:Symptoms of overdose
- Abdominal or stomach pain
- lack or loss of strength
Some side effects of afatinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Blemishes on the skin
- canker sores
- chapped, red, or swollen lips
- decreased appetite
- decreased weight
- dry skin
- itching skin
- loosening of the fingernails
- redness or soreness around the fingernails
- runny nose
- scaling, redness, burning, pain, or other signs of inflammation of the lips
- sores, ulcers, or white spots on the lips or tongue or inside the mouth
For Healthcare Professionals
Applies to afatinib: oral tablet
The most frequent serious adverse reactions reported were diarrhea (6.6%); vomiting (4.8%); and dyspnea, fatigue, and hypokalemia (1.7% each). Fatal adverse reactions included pulmonary toxicity/ILD-like adverse reactions (1.3%), sepsis (0.43%), and pneumonia (0.43%).
Dose reductions due to adverse reactions were required in 57% of patients. The most frequent adverse reactions that led to dose reduction were diarrhea (20%), rash/acne (19%), paronychia (14%), and stomatitis (10%).
Discontinuation of therapy for adverse reactions was 14.0%. The most frequent adverse reactions that led to discontinuation were diarrhea (1.3%), ILD (0.9%), and paronychia (0.9%).
Very common (10% or more): Diarrhea (96%), stomatitis (71%), cheilitis (12%)
Very common (10% or more): Acneiform rash/dermatitis (90%), paronychia (58%), dry skin (31%), pruritus (21%)
Very common (10% or more): Cystitis (13%)
Very common (10% or more): Alanine aminotransferase increased (11%)
Common (1% to 10%): Aspartate aminotransferase increased (8%)
Very common (10% or more): Decreased appetite (29%), weight decreased (17%)
Very common (10% or more): Conjunctivitis (11%)
Very common (10% or more): Pyrexia (12%)
Very common (10% or more): Epistaxis (17%), rhinorrhea (11%)
More about Gilotrif (afatinib)
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